Prescription drug · ANDA
Colestipol hydrochloride NDC 70771-1653
Colestipol hydrochloride 1 g/1 · Tablet, Film coated · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1653-5 | 7077116530570771165305 | 500 TABLET, FILM COATED in 1 BOTTLE (70771-1653-5)Marketed from May 4, 2022 | |
| 70771-1653-7 | 7077116530770771165307 | 120 TABLET, FILM COATED in 1 BOTTLE (70771-1653-7)Marketed from May 4, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Colestipol hydrochloride
- Generic name (nonproprietary)
- colestipol hydrochloride
- Active ingredients
- Colestipol hydrochloride — 1 g/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Zydus Lifesciences LimitedNDC labeler code 70771
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215223
- Marketing start
- Listing expires
- Other FDA classes
- Bile-acid Binding Activity (Mechanism)
- Identifiers
- Product ID 70771-1653_e5237070-d3ba-4dd6-921d-7ec80d8bc251SPL ID e5237070-d3ba-4dd6-921d-7ec80d8bc251SPL set ID 3b451f0b-5bd9-419a-afa2-a02eb0bbc45eRxCUI 1048445UNII X7D10K905GUPC 0370771165377
- Pharmacologic class
- Bile Acid Sequestrant
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N470771165305followed by a unit qualifier and the quantityPackage 70771-1653-05. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
About NDC 70771-1653
- What is NDC 70771-1653?
- 70771-1653 is the product NDC for Colestipol hydrochloride, Colestipol hydrochloride 1 g/1 tablet, film coated, listed with the FDA by Zydus Lifesciences Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Colestipol hydrochloride.
- What is the active ingredient?
- Colestipol hydrochloride.
- Who is the labeler?
- Zydus Lifesciences Limited, NDC labeler code 70771. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Colestipol hydrochloride?
- 11 other product NDCs are listed under this name. See all Colestipol hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Colestipol hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Colestipol Hydrochloride | Colestipol hydrochloride 1 g/1 | Tablet, Film coatedOral | NorthStar Rx LLC | 72603-817 | 72603-0817-01 |
| Colestipol Hydrochloride | Colestipol hydrochloride 1 g/1 | Tablet, Film coatedOral | Ingenus Pharmaceuticals, LLC | 50742-284 | 50742-0284-12 |
| Colestipol Hydrochloride | Colestipol hydrochloride 1 g/1 | TabletOral | Edenbridge Pharmaceuticals LLC. | 42799-115 | 42799-0115-01 |
| Colestipol Hydrochloride | Colestipol hydrochloride 1 g/1 | Tablet, Film coatedOral | ANI Pharmaceuticals, Inc. | 62559-395 | 62559-0395-12 |
| Colestipol Hydrochloride | Colestipol hydrochloride 1 g/1 | Tablet, Film coatedOral | American Health Packaging | 60687-715 | 60687-0715-21 |
| Colestipol hydrochloride | Colestipol hydrochloride 1 g/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 70710-1467 | 70710-1467-0570710-1467-07 |
| Colestipol Hydrochloride | Colestipol hydrochloride 1 g/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals of New York LLC | 0115-5211 | 00115-5211-0200115-5211-16 |
| Colestipol Hydrochloride | Colestipol hydrochloride 5 g/1 | SuspensionOral | Amneal Pharmaceuticals of New York LLC | 0115-5212 | 00115-5212-1800115-5212-29 |
| Colestipol Hydrochloride | Colestipol hydrochloride 5 g/1 | SuspensionOral | Amneal Pharmaceuticals of New York LLC | 0115-5213 | 00115-5213-02 |
| Colestipol Hydrochloride | Colestipol hydrochloride 1 g/1 | TabletOral | Mylan Pharmaceuticals Inc. | 59762-0450 | 59762-0450-01 |
Other NDCs under ANDA 215223
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Colestipol hydrochloride | Colestipol hydrochloride 1 g/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 70710-1467 |